我国超说明书用药规制环境研究  

A Research on the Regulation Circumstance of the Off-Label Use of Drug in China

作　　者：刘利军[1] 肖龙华[1] 王津雨[1] 李睿[1] 

机构地区：[1]中国医学科学院北京协和医学院血液学研究所血液病医院医务处,天津300020

出　　处：《中国医药导刊》2014年第6期1101-1102,共2页Chinese Journal of Medicinal Guide

摘　　要：目的:厘清中国超说明书用药的规制环境。方法:文献综述与知情人深度访谈。结果:目前并无针对性的法律或法规,超说明书用药法律性质的界定难度很大。结论:加强超说明书用药管理,加强超说明书用药相关问题研究,以尽快推动超说明书用药立法。Objective：To analysis the regulation circumstance of the off-label use drug.Methods：In-depth interview were used in this study.Results：There are none regulation for the off-label use drug in China today;It is hard to know whether an off-label use drug is anti the regulation.Conclusion：The research on off-label use of drug should be strengthened and the legislation on it should be established rapidly.

关 键 词：超说明书用药 现状 规制环境 

分 类 号：R95[医药卫生—药学]